Rib fractures are very painful, especially if multiple ribs are fractured simultaneously. This is especially true while breathing, and as a result the patient tends to breathe flatly (reduced forced vital capacity, FVC), or, in case of multiple fractures on the same rib, forcing the patient to breath in an unusual way, in which the chest parts participating in breathing move in the opposite direction as usual. In most rib fracture cases, no surgical intervention is performed, and natural healing occurs. It is desirable to administer some medicine for controlling the pain of the patient in order to achieve better breathing.
The immobilization of fractured ribs presents an unique splinting challenge due to their localization. Proper splinting technique teaches that a splint should extend to include the joint on either side of the injury. Applying this general rule to the case of rib fractures would mean a circumferential brace or belt which wraps around the body. This technique was introduced by Malgaine (1859), however it is medically rather contraindicated today. This is because—due to the inhibition of the breathing—the risk of pneumonia is greatly increased in such cases. The various trials after Malgaine with taping or surgical approaches were all failures, owing to either a lack of any therapeutic advantage or the costs (e.g., with surgical approaches).
In the fact, the target of splinting is an immobilized limb in the classic bone fracture case. This lies in stark contrast to a chest injury, in which body part that moves steadily and three-dimensionally has to be splinted. In this regard, it is worth noting that the average human performs about 20,000 breathing cycles per day! This substantial difference has made it impossible even for experts to apply the results or observations of the usual splinting techniques the splinting of a rib fracture.
On one hand, a rib splint must be wide-based and must over-bridge the fracture region. As noted above, circular bandaging cannot be used without inhibiting the breathing capacity. On the other hand, the larger the splint, the stronger the forces exerted by each breathing cycle to diminish the effect of the adhesive at its periphery. The whole splint has to be rigid (and also formable at the same time) to reduce all the forces resulting from the different movements of the ribs. However, an appropriate degree of flexibility of the material may also be desirable for the patient's comfort. No known arrangement complies with these criteria before the present device and method.
It has already been known for a long time that for immobilizing fractured ribs, the side with the fracture in the thorax can be fixed by an adhesive plaster, in order to reduce the movement of the fractured rib. However, this is usually not sufficient. There is a suggestion (GB-A-624,425) to use bundle-like, stretchable stripes instead of the plaster, which can be prestreched by means of a releasable stretching device. However, those immobilizing devices ensure a limited mobility in the region of the fracture, but, at the same time, they hinder breathing to a large extent, as well.
The earlier mentioned description U.S. Pat. No. 4,312,334 suggests binding a frame around the patient. The front side of the frame consists of two vertical, arched supporting elements over the chest. The indented part of the thorax in the fracture area is drawn out by means of a wire fixed on its one end to the chest and on the other end to the supporting element. In this way, the fractured ribs can be kept in a position suitable for healing, easing the pain that reduces breathing.
The drawbacks of this arrangement include the necessary intervention, the difficulty in positioning the wire, and the hindering of the patient's movements by the stretched wire and the frame.
Shippert (1980; U.S. Pat. No. 4,213,452) describes a “compound” splint, primarily for use after nasal surgery. The splint is put together on the patient. Adhesive tapes are used as a basic layer for securing a secondary component followed by a malleable metal sheet and the closing layer(s). This reference makes no suggestion of possible use in rib fracture, and in fact concerns itself only with a small and immobilized area. It is entirely unsuitable for use in connection with a larger and moving area, such as the chest.
Groiso (1986; U.S. Pat. No. 4,852,556) describes an orthopedic rigid splint-plate orthesis of different sizes and forms depending on the target of the immobilization. One of the claimed targets is a rib fracture. The material used requires a curing process, and any mention of an adhesive in such reference is proposed only in connection with such curing period. Groiso acknowledges that for securing a bigger thermoplastic splint, adhesive attachment is not sufficient. Accordingly, he uses a circumferential wrapping around the body. In fact, the possible positive effect of his method is based on the circular bandaging of the thorax, a technique used since the middle of the nineteenth century.
Erickson (WO-A1-89/05620) provides a fixing plate for rib fractures being flexurally rigid in the longitudinal direction, and to a certain extent flexible in the direction perpendicular to this. In addition, it is to a certain extent also rotatable in the diagonal direction (being able to torsion). This arrangement serves for supporting and fixing the individual fractured ribs on the one hand, and at the same time, should make free breathing movement of the patient possible, on the other hand. This objective is achieved by using a plate made of a flexible, elastic material, such as rubber or plastic, in which several closed, long-shaped cavities parallel to the longitudinal, flexurally rigid direction are arranged. In each of these cavities, freely movable, as one-dimensional splint elements, rods made of an inelastic but deformable material are arranged. In case of a rib fracture, due to their deformability, these splints can be fitted to the contour of the rib. The plate with the splints will be stuck flat to the chest, in this position the splints run parallel to the ribs. Thus, the ribs are fixed in the longitudinal direction, whereas at normal breathing, the chest is able to expand without hindrance.
Though the one-dimensional splints fix the fractured ribs in the longitudinal direction, they allow for unhindered movement of the ribs relative to each other for breathing. This is partly due to the free movability of the splints in the cavities. Due to this movability of the ribs relative to each other during breathing, the distances between individual ribs change. As a result, the fractured sites of the ribs may rub on each other, causing pain for the patient. This pain may lead to a cramp in the intercostal musculature, which only exacerbates the pain.
Bolla et. al. (1996; U.S. Pat. No. 6,039,706) describes a medical splint, metal sheets for such a splint, and its use for securing and immobilizing movable body parts in particular extremities. The specially prepared material ensured “a high shapability and stiffness at the same time.” It is rigid and formable at the same time, a ready-to-use splinting material without the necessity of a curing process. This reference proposes the device for use only for conventional (e.g., limb) splinting. Splinting of the thorax (rib fracture) is not suggested as appropriate for such device. The breathing-related, nearly continuous movement of the thorax excludes such an application without a belt.
Singh et. al. (2000; U.S. Pat. No. 6,716,186 B1) describes curable adhesive splints and methods. The splints include at least a curable splinting layer (developing the requested stiffness) and an adhesive one. The declared target of the splinting is “Immobilization of smaller skeletal features, such as fingers or of oddly shaped skeletal features, such as noses . . . .” The use of the claimed technique for ribs is not mentioned. The inventors seemingly knew the substantial differences in the requirements between splinting an immobilized body part and a steadily moving one, such as the thorax. The device described in this patent could only be used in connection with a rib fracture (if at all) with an additional belt. This, however, is already the subject of the Groiso reference described above (1986; U.S. Pat. No. 4,852,556). The securing of the splint position with an adhesive layer, as Groiso describes, can be utilized for larger splints only with the additional wrapping necessitated thereby. He secures the rib splint from similar materials, with an adhesive used only during the curing process.
Rolnik et. al. (2004; U.S. Pat. No. 6,971,995) proposes an adhesive elastic splint construction for the treatment of rib injuries. He even disclaims the applying of an inelastic adherent patch even because it is asserted not to be appropriate for allowing the patient's comfort.